MelanomaPhase 1NCT01946373
T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma
A Phase 1 study testing Cyclophosphamide, Fludarabine and T cells in people with Melanoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Cyclophosphamide, Fludarabine and T cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with measurable (direct on body surface or by x-ray and/or CT) malignant melanoma (including uveal melanoma), that is advanced, inoperable stage III (advanced regional lymph node metastases, or more than 5 in-transit metastases, N2) or stage IV (distant metastasis, M1) according to the AJCC classification and confirmed by histology/cytology and appropriate radiological investigations.
- Patients with a palpable resectable lesion located in the skin or in a lymph node or a lesion accessible by (core) biopsy.
- Disease should be in progression and the patient should have exhausted other approved therapeutic options, if not the physician considers that an earlier study entry benefits the patient.
- Ambulatory performance status (ECOG 0, 1, 2).
- Age 18-74 and life expectancy greater than 3 months.
Who cannot join
- Any of the above criteria are not met.
- Significant history or current evidence of cardiovascular disease (e.g. uncontrolled congestive heart failure or hypertension, unstable coronary artery disease or serious arrhythmias) or major respiratory diseases. In questionable cases, a stress test should be performed.
- Recipients of a major organ allograft. Autoimmune diseases such as, but not limited to, inflammatory bowel disease or multiple sclerosis. Vitiligo is not an exclusion criterion. Other serious chronic diseases.
- Other serious illnesses, e.g. active infections requiring antibiotics, bleeding disorders.
- Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen.
- Patients diagnosed with prior malignancies (except adequately treated basal cell carcinomas of the skin or in situ carcinomas of the skin or in situ carcinomas of the cervix, surgically cured) within the past 5 years.
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- Patients with second advanced malignancies concurrently.
- Active CNS metastases. (Note: Patients with brain metastases that have been completely resected at least one month prior to registration or have undergone gamma knife treatment with no evidence of recurrence on CT and who are neurologically stable, are not excluded).
- Organic brain syndrome or significant psychiatric disorder which would preclude participation in the full protocol and follow-up.
- Immunodeficiency, previous splenectomy or radiation therapy of the spleen.
- Screening laboratory values:
- Inadequate hematologic function defined by: i) White blood count (WBC) <3.0 x 109/l ii) Platelet count <100x109/l iii) Hemoglobin level <100 g/l b) Inadequate hepatic function as defined by either: i) Total bilirubin level >1.5 times the upper limit of normal (ULN) ii) Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN) c) Inadequate renal function defined as serum creatinine >1.5 times the ULN
- Infectious diseases that can be transmitted via contact with blood, such as HIV, Hepatitis B and C.
- Women who are pregnant or nursing will be excluded because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, SE-171 76
Maria Wolodarski, MD, +46851770000, maria.wolodarski@regionstockholm.se
Maria Wolodarski, MD
About this study
Official title: A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma
The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.
Read the detailed description
The MAT02 clinical trial is a phase 1 clinical trial with the objective to assess the safety, feasibility and immunological efficacy of the combined application of two immunological treatment modalities in patients with metastatic melanoma:
- Cohort A: After a non-myeloablative conditioning regimen, 5 patients will receive one bulk infusion of T cells. T cells will be expanded ex vivo from autologous tumor infiltrating lymphocytes (TIL). In vivo persistence of the infused cells will be supported by administration of IL-2, a T cell survival factor.
- Cohort B: This adoptive cell transfer (ACT) step will in additional 10 patients be followed by a vaccination with autologous, in vitro-generated, dendritic cells (DC), loaded with autologous tumor lysate and a synthetically produced peptide derived from the tumor associated antigen NY-ESO 1.
- Conditions
- Melanoma
- Being tested
- Cyclophosphamide, Fludarabine, T cells, Interleukin-2, Dendritic cell vaccine
- Keywords
- Melanoma, Dendritic cell vaccination, Lymphodepletion, Adoptive cell transfer, T cells, Tumor infiltrating lymphocytes, Fludarabine, IL-2, Interleukin-2, Cyclophosphamide, Phase I study, Monocytes, Autologous, NY-ESO-1
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Sendoxan, Cytoxan, Neosar
FludarabineDrug
Also called Fludarabine phosphate, Fludara
T cellsBiological
Interleukin-2Biological
Also called IL-2, Proleukin
Dendritic cell vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + T cells + IL-2 | Experimental | Cyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: T cells; Biological: Interleukin-2 |
| Chemotherapy + T cells + IL-2 + DCV | Experimental | Cyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses. After completion of the IL-2 treatment 3-5 doses of weekly intradermal vaccinations with up to 1.5 x 10^7 Dendritic cells pulsed with autologous tumor lysate and NY-ESO-1 peptide. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: T cells; Biological: Interleukin-2; Biological: Dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the T cell therapy, with and without dendritic cell vaccine, as evaluated according to the NCI CTCAE scale version 4.0
Measured: 30 days
Secondary outcomes (1)
Time to disease progression assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Wolodarski, Karolinska University Hospital
- Investigators
- Maria Wolodarski, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946373
- Sponsor's protocol ID
- MAT-02
- Other IDs
- 2012-000450-63
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2013
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01946373
- Acronym / sponsor ID
- MAT-02
- Conditions
- Melanoma
- Keywords
- Melanoma, Dendritic cell vaccination, Lymphodepletion, Adoptive cell transfer, T cells, Tumor infiltrating lymphocytes, Fludarabine, IL-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.
Detailed description
The MAT02 clinical trial is a phase 1 clinical trial with the objective to assess the safety, feasibility and immunological efficacy of the combined application of two immunological treatment modalities in patients with metastatic melanoma:
- Cohort A: After a non-myeloablative conditioning regimen, 5 patients will receive one bulk infusion of T cells. T cells will be expanded ex vivo from autologous tumor infiltrating lymphocytes (TIL). In vivo persistence of the infused cells will be supported by administration of IL-2, a T cell survival factor.
- Cohort B: This adoptive cell transfer (ACT) step will in additional 10 patients be followed by a vaccination with autologous, in vitro-generated, dendritic cells (DC), loaded with autologous tumor lysate and a synthetically produced peptide derived from the tumor associated antigen NY-ESO 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + T cells + IL-2 | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: T cells, Biological: Interleukin-2Cyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses. |
| Chemotherapy + T cells + IL-2 + DCV | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: T cells, Biological: Interleukin-2, Biological: Dendritic cell vaccineCyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses. After completion of the IL-2 treatment 3-5 doses of weekly intradermal vaccinations with up to 1.5 x 10^7 Dendritic cells pulsed with autologous tumor lysate and NY-ESO-1 peptide. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with measurable (direct on body surface or by x-ray and/or CT) malignant melanoma (including uveal melanoma), that is advanced, inoperable stage III (advanced regional lymph node metastases, or more than 5 in-transit metastases, N2) or stage IV (distant metastasis, M1) according to the AJCC classification and confirmed by histology/cytology and appropriate radiological investigations.
- Patients with a palpable resectable lesion located in the skin or in a lymph node or a lesion accessible by (core) biopsy.
- Disease should be in progression and the patient should have exhausted other approved therapeutic options, if not the physician considers that an earlier study entry benefits the patient.
- Ambulatory performance status (ECOG 0, 1, 2).
- Age 18-74 and life expectancy greater than 3 months.
Key exclusion criteria (14 listed)
- Any of the above criteria are not met.
- Significant history or current evidence of cardiovascular disease (e.g. uncontrolled congestive heart failure or hypertension, unstable coronary artery disease or serious arrhythmias) or major respiratory diseases. In questionable cases, a stress test should be performed.
- Recipients of a major organ allograft. Autoimmune diseases such as, but not limited to, inflammatory bowel disease or multiple sclerosis. Vitiligo is not an exclusion criterion. Other serious chronic diseases.
- Other serious illnesses, e.g. active infections requiring antibiotics, bleeding disorders.
- Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: Sendoxan, Cytoxan, Neosar | Drug | Chemotherapy + T cells + IL-2, Chemotherapy + T cells + IL-2 + DCV |
| FludarabineAlso: Fludarabine phosphate, Fludara | Drug | Chemotherapy + T cells + IL-2, Chemotherapy + T cells + IL-2 + DCV |
| T cells | Biological | Chemotherapy + T cells + IL-2, Chemotherapy + T cells + IL-2 + DCV |
| Interleukin-2Also: IL-2, Proleukin | Biological | Chemotherapy + T cells + IL-2, Chemotherapy + T cells + IL-2 + DCV |
| Dendritic cell vaccine | Biological | Chemotherapy + T cells + IL-2 + DCV |
Primary outcome
Safety of the T cell therapy, with and without dendritic cell vaccine, as evaluated according to the NCI CTCAE scale version 4.0
Time frame: 30 days
1 secondary outcome
Time to disease progression assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Wolodarski, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and T cells in people with Melanoma, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Wolodarski, MD (+46851770000, maria.wolodarski@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the T cell therapy, with and without dendritic cell vaccine, as evaluated according to the NCI CTCAE scale version 4.0 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.